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Completed

NCT Number: NCT03444441

Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments

The present study investigates the minimal important change and validity of foot and ankle measures.

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Key information

Conditions

Foot Diseases Ankle Disease Musculoskeletal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Finland Central Hospital, Jyväskylä, Finland

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About this study

Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided.

The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full understanding of Finnish language
  • Undergoing foot or ankle surgery
  • At least 18 years old

Exclusion criteria

  • Unbalanced mental disorder such as schizophrenia or depression
  • Age under 18
  • Does not understand Finnish
  • Undergoing operation other than foot or ankle

Treatment and study plan

Foot or ankle surgery

Procedure

Surgery for foot or ankle

Other names: correction forefoot, correction midfoot, correction hindfoot, correction ankle, combined correction, procedures for osteoarthritis foot or ankle, procedures for instability ankle, correction flatfoot, correction cavus foot, correction equinus foot, procedures for Diabetic ulcer, procedures for Charcot, procedures for tendinopathy Achilles, procedures for tendinopathy other, osteosynthesis, Other foot or ankle surgery

Primary outcomes

  1. Minimal important difference

    Time frame: Baseline, 6 months

    Change from baseline scores at 6 months

Secondary outcomes

  1. Reliability

    Time frame: 6 months, 6.5 months

    Change from 6 months scores at 6.5 months

  2. General health question

    Time frame: Baseline, 6 months

    Change from baseline scores at 6 months

  3. General health question

    Time frame: 6 months, 6.5 months

    Change from baseline scores at 6 months

  4. Global assessment scale

    Time frame: 6 months

    Change from baseline scores at 6 months

  5. Validity

    Time frame: Baseline

    Baseline scores

  6. Validity

    Time frame: 6 months

    6 months scores

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Central Finland Hospital District
  • Oulu University Hospital
  • Seinajoki Central Hospital

Registry information

Official study title

Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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